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A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes
Plain-language guide to NCT06649344: phase 3 randomized trial of Semaglutide, 884 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06649344
- Phase
- phase 3
- Status
- completed
- Start
- 2024-10-31
- Completion (planned or actual)
- 2026-07-18
- Participants
- 884 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Semaglutide.
It had three arms (groups): Treatment group A (experimental), Treatment group B (experimental) and Treatment group C (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 884 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diagnosed with type 2 diabetes ≥ 90 days；.
The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: known or suspected allergy or intolerance to the investigational medicinal products or related products；; acute complications of diabetes occurred during the previous 6 months；; serious chronic complications of diabetes in the past；.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Semaglutide study did not mask who received what.
It started in 2024-10-31 with completion listed for 2026-07-18.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change in HbA1c (time frame: Week 0 to Week 36).
It also tracked 7 secondary outcomes, for example Change in body weight, Change in FPG (fasting plasma glucose), Change in FPG (fasting plasma glucose), 7-points SMPG profiles and Incidence and severity of adverse events.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Semaglutide in 884 people.
With 884 participants it is a large trial for this field.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.